Bicara Therapeutics Shares Early Trial Results Backing FDA-Supported Fast-Track Drug

Bicara Therapeutics Inc. (NASDAQ:BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced the publication of an abstract with early data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa weekly (QW) in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The results will be highlighted in an oral presentation at the upcoming European Society for Medical Oncology (ESMO) Asia Congress and will be discussed on a company conference call and webcast on Saturday, December 6, at 9:00 a.m. ET.

"The preliminary data for 750mg of ficerafusp alfa are encouraging, with a consistently high overall response rate now observed across both dose levels of ficerafusp alfa under evaluation for the optimal biologic dose for our ongoing, pivotal FORTIFI-HN01 study," said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. "Importantly, these results provide valuable context around the safety and efficacy profile of ficerafusp alfa in patients with HPV-negative head and neck squamous cell carcinoma and were used to support our FDA Breakthrough Therapy Designation. The consistent overall response rate across both doses of ficerafusp alfa reinforces our confidence that the interim analysis in the pivotal trial could support accelerated approval."

Presentation Details

Title: Ficerafusp alfa 750 mg QW and pembrolizumab in HPV-negative first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)

Abstract #: 6670

Session Name: Proffered Paper session: Head and neck cancer

Presentation Date and Time: Saturday, December 6, 2025, 4:50 – 5:00 p.m. SGT / 3:50 – 4:00 a.m. EST

Presenter: Deborah J. Wong, MD, PhD, Director of the Head and Neck Medical Oncology Program, UCLA

Location: Hall 401, Suntec Singapore, Singapore, Singapore

Key highlights of the abstract include:

• Expansion cohort data (July 9, 2025 cutoff date) from the Phase 1/1b clinical trial of ficerafusp alfa in patients with 1L HPV-negative R/M HNSCC evaluating 750mg of ficerafusp alfa weekly in combination with pembrolizumab.
• In the efficacy evaluable population (n=30):
  • 57% (17/30) objective response rate, including 50% (15/30) of patients who achieved a partial response and 7% (2/30) of patients who achieved a complete response.
  • 83% (n=25/30) disease control rate.
  • Complete, prolonged neutralization of TGF-β1 observed.
• Safety findings were consistent with the known safety profile of ficerafusp alfa plus pembrolizumab in R/M HNSCC.